BPI Labs LLC
Form 483 issued April 17, 2026 · Largo, Florida
- Inspection
- Apr 6 – Apr 17, 2026
- Investigator
- Lisa R. Hilliard
- Observations
- 4
- Pages
- 8
- FEI number
- 3015156709
In short: On April 17, 2026, FDA issued a Form 483 with 4 observations to BPI Labs LLC in Largo, Florida (FEI 3015156709) after an inspection that ran Apr 6 – Apr 17, 2026. The investigator was Lisa R. Hilliard. Most observations concern production and quality system.
At a glance
Observations span 4 systems, led by production.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Observation 1: scanned text, readable in the full document.
- 02
The responsibilities and procedmes applicable to the quality control unit are not in…
- 03
The written stability program for drug products does not include reliable, meaningful…
- 04
Written procedmes are not established and followed for the cleaning and maintenance of equipment, including utensils…
This inspection in context
Lisa R. Hilliard
15 documents · 2021–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Ohio.
The firmBPI Labs LLC history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.22
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at BPI Labs LLC?
FDA listed 4 observations on this Form 483, mostly about production, quality system and laboratory controls. The opening words of each observation are shown on this page.
Who inspected BPI Labs LLC?
Lisa R. Hilliard is named on this Form 483, for the inspection of Apr 6 – Apr 17, 2026. Each investigator has a profile showing what they cite most.
When was BPI Labs LLC inspected by FDA?
The inspection ran Apr 6 – Apr 17, 2026, and the Form 483 is dated April 17, 2026.
How do I get the full Form 483 for BPI Labs LLC?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.